When we cut ourselves, we automatically reach for a Band-Aid®. Why? It stops the bleeding and we can quickly return to whatever we were doing before the accident happened. Without a lot of fuss, we resolve a messy situation and expect the cut to heal in a few days. Having a box of these adhesive strips on hand allows us to reach for them again and again. The danger in applying a Band-Aid so automatically is that we fail to stop and inspect just how deep the wound really is. Maybe it will just heal on its own, we hope. So why are we surprised when the bleeding starts again after the Band-Aid is removed?
Root cause fixes can be applied a lot like Band-Aids; a quick solution to stop the bleeding and hope the problem solves itself. When the problem returns again or worsens, we realize that our quick fix might have backfired into something more. Peter Senge, author of "The Fifth Discipline Fieldbook," describes this as "Fixes that Backfire." His model depicts a two-cycle process. The cycle begins at the onset of a problem and we quick-fix (put on a Band-Aid) the problem. Solving the problem quickly allows us to get back to the task at hand. Unfortunately, the original problem wasn't solved; but the symptom went away temporarily so we fool ourselves into thinking it's solved. Over time, however, the cycle repeats itself with intensity and becomes a bigger problem than at first glance.
A discrepancy means that there is a difference between what was expected and the result. It becomes a deficiency, nonconformity, anomaly, etc. when someone has evaluated the result as unacceptable. In most case, this means departure from the SOP, policy, or CFR regulations. And so begins the root cause analysis quest to find "the why" did it happen. Typically, the analysis begins with a focus on the event and the elements of the "story." We ask the five universal problem-solving questions: who, what, where, when and how. But we need to abstain from asking why at this point and continue uncovering possible causes.
The results will provide answers that form the basis of possible causes; not just the first one that comes to mind. Upon a closer look, these answers can be grouped into three levels.
2nd Level - Task/Process: The investigation needs to review the design of the procedures, materials, and facilities to identify weaknesses that can occur up to and including the point of discovery.
3rd Level - Systems: This involves an analysis of how the procedures, policies, initiatives, etc. are being followed and whether Management Review is being conducted properly. This includes the feedback loops and systems performance results. By reviewing the situation from all three levels, your search for the true root cause takes on a deeper focus; one that will be more effective in stopping "the fixes that backfire."
The best corrective actions are the ones that map back to the root cause. By grouping typical performance gaps into clusters, you can do the same with corrective actions. The American Society for Training and Development offers a six-box model for improving performance gaps. Why not use these same categories to draw upon for corrective actions? For example, when there is a lack of confidence to use the skills, provide practice, feedback and mentoring. If the root cause points to task interference and other obstacles, provide corrective actions that improve physical resources and/or processes.
So, the next time a problem presents itself, rather than fumbling for the box of Quick-Fix solutions, try moving beyond the event to look at the performer, the task and the systems contributing to the problem to find the true root cause the first time and apply a six-box solution instead.
Vivian Bringslimark has more than 20 years of experience as a field practitioner within the Life Sciences community, serving in various professional and management positions as well as consulting internally and externally on diverse assignments. She currently serves as president of HPIS Consulting Inc., partnering with clients to analyze true root causes of human performance gaps and implementing appropriate solutions that align with stated business outcomes to bring about more long-term and predictable performance, resulting in yearly goal achievement and operational excellence. She worked previously for Parexel Consulting and is frequently sought as a guest speaker for training conferences. Reach Vivian at (203)-270-6519 or email@example.com. Visit her website at www.hpisconsulting.com.
ORA Laboratory Manual, Corrective Action Procedure ORA-LAB 411 http://www.fda.gov/ora/science_ref/lm/Volume_2_ISO_17025_ORA_Laboratory_Procedures/Section_1_-_Management_Requirements(Templates)/ORA-LAB.4.11.html
Bringslimark, Vivian. "Management Engagement: The Key to Quality Systems", BioProcess, April, 2008. http://www.bioprocessintl.com/default.asp?page=article_display&docid=40120082&display=full